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The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions.

The RECON system consists of various system components and it is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.

The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws:

• Microcan 1.8/2.3 ●
• . Maxican 4.5
• CBS Micro Compression ●
• CBS High Compression
• CBS 4.5/7.5 ●
• V-TEK Micro 2.0 ●
• V-TEK Standard 3.0 ●

screws of different sizes and designs.

The screws and washers are made of titanium alloy Ti-6AI-4V (ASTM F136).

The implants are offered in various sizes to accommodate the variations of bone size and geometry as well as plate sizes and configurations.

The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.

This document is a 510(k) premarket notification for the RECON system - Compression Screws. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (bone fixation fasteners), acceptance criteria are typically related to mechanical performance and biocompatibility. The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance values. Instead, it states that the device's performance was found to be "similar" or "substantially equivalent" to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for mechanical testing or biocompatibility. It only mentions "testing on screws, and washer material" and "self-tapping performance, driving and removal torque, torgue to failure and axial pullout of the RECON system- compression screws and the predicate devices."

• Test Set Sample Size: Not explicitly provided.
• Data Provenance: Not explicitly stated, but it can be inferred that the testing was conducted by or for Normed Medizin-Technik GmbH, likely in Germany (based on their address). The data is retrospective in the sense that it evaluates a completed device design against established benchmarks.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to mechanical and biocompatibility testing for a bone fixation device. Ground truth, in this context, refers to a definitively correct answer, which for mechanical properties is determined by physical measurements and for biocompatibility by laboratory assays. The "experts" would be the engineers and scientists conducting and interpreting these tests, whose qualifications are implied by their role in such studies (e.g., biomedical engineers, materials scientists, toxicologists). No specific number or qualifications are given beyond the fact that the tests were performed according to recognized standards (ISO 10993-1).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human interpretation of ambiguous data is involved to establish a consensus ground truth. For mechanical and biocompatibility tests, results are typically objective measurements against defined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a surgical implant (bone fixation fastener), and its effectiveness is primarily assessed through mechanical performance and biocompatibility, not by human reader interpretation. Therefore, there is no mention of such a study or an effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a physical surgical implant, not an algorithm or software. It does not have "standalone performance" in the context of an algorithm.

7. Type of Ground Truth Used

• Mechanical Testing: The ground truth for mechanical testing is based on objective physical measurements (e.g., torque values, pullout strength) compared against established performance characteristics of predicate devices and relevant engineering standards.
• Biocompatibility: The ground truth for biocompatibility is based on laboratory test results (e.g., cytotoxicity, sensitization, irritation) evaluated against the criteria outlined in ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI or machine learning model. Therefore, there is no "training set" in the conventional sense. The design and manufacturing processes are likely informed by years of engineering knowledge and experience with similar devices, but not a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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